Clinical Trial of Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine

What Was Tested

In this phase 4 trial, researchers set out to test Leuprolide.

It had two arms (groups): Ziyinxiehuo Granules and Megestrol Acetate (experimental) and Gonadotrophin (active comparator).

The registry classes the interventions as drug.

More on the Plan

In the research, 164 subjects diagnosed with rapid progressive idiopathic precocious puberty are randomly divided into Group Ziyinxiehuo Granules and Megestrol Acetate Tablet（82 cases）and Group Gonadotrophin ( 82 cases).

Patients in Group Ziyinxiehuo Granules and Megestrol Acetate Tablet are treated with ziyinxiehuo Granules and megestrol acetate tablet , whereas the Group Gonadotrophin received with gonadotrophin releasing hormone agonist, and all the subjects in two groups are continuously treated for 6 months.

Who Took Part

126 actual participants took part.

It was open to women only aged from 5 years up to 8 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Girls are diagnosed as Idiopathic central precocious puberty by GnRH （gonadotrophin releasing hormone）Stimulation Test, and their age of onset ≤8 years;. Tanner stages of breast in female patients ≥ Tanner III stage，diameter of mammillary nucleus ≥ 3cm;. Bone age: compared the chronological age, the bone age is more than 1 year and the bone age \<11.5 years old;. It progresses rapidly, ratio of bone age difference to chronological age difference\> 1;. No GnRH analogs or sex hormones were administrated in the past;.

The full record lists 7 inclusion and 4 exclusion criteria; among the exclusions: precocious precocity caused by the central nervous system organic diseases;; precocious precocity caused by congenital hypothyroidism, congenital adrenal hyperplasia, adrenal tumor and ovarian or testicular neoplasms as well as mccune-albright syndrome, etc;; precocious precocity with a family history of diseases such as tumor, leukemia, diabetes, systemic lupus erythematous;.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.

It started in 2019-08-15 with completion listed for 2022-08-15.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Ratio of bone age difference to chronological age difference.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Leuprolide in 126 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, all human trials.